A Study of LY3454738 in the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
- Registration Number
- NCT05911841
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe atopic dermatitis (AD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 236
- Are candidates for systemic therapy.
ISA specific:
-
Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:
- EASI score greater than or equal to (≥)16
- vIGA-AD score ≥3, and
- ≥10% of BSA involvement (per EASI BSA).
-
Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.
ISA specific:
- Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
- Are currently being treated with topical or systemic therapy
- Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3454738 Dose 1 LY3454738 Participants will receive LY3454738 subcutaneously (SC). Placebo Placebo Participants will receive placebo. LY3454738 Dose 3 LY3454738 Participants will receive LY3454738 SC. LY3454738 Dose 2 LY3454738 Participants will receive LY3454738 SC.
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Eczema Area and Severity Index (EASI) 75 Week 16
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 Week 16 Percentage of Participants Achieving Validated Investigator's Global Assessment for AD (viGA-AD) of 0 or 1 Week 16 Mean Percent Change from Baseline in EASI Baseline, Week 16 Percentage of Participants Achieving EASI-75 Week 16 Percentage of Participants Achieving SCORAD-90 Week 16 Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738 Baseline to Week 16 Percentage of Participants Achieving EASI-90 Week 16 Mean Percent Change from Baseline in SCORAD Baseline, Week 16 Percentage of Participants Achieving EASI-50 Week 16 Percentage of Participants Achieving ≥4-point improvement from baseline in Itch Numeric Rating Scale (NRS) in the Subset of Participants with ≥4-point Itch NRS at Baseline Week 16
Trial Locations
- Locations (65)
Johnson Dermatology
🇺🇸Fort Smith, Arkansas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Encore Medical Research
🇺🇸Hollywood, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
Allergy and Asthma Specialist
🇺🇸Owensboro, Kentucky, United States
Arkansas Research Trials
🇺🇸North Little Rock, Arkansas, United States
Revival Research Institute, LLC
🇺🇸Troy, Michigan, United States
ActivMed Practices & Research, Inc.
🇺🇸Portsmouth, New Hampshire, United States
Metropolitan Dermatology - Clark
🇺🇸Kenilworth, New Jersey, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
DermDox Centers for Dermatology
🇺🇸Camp Hill, Pennsylvania, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
Rejuvenation Dermatology
🇨🇦Edmonton, Alberta, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
CCA Medical Research
🇨🇦Ajax, Ontario, Canada
Hamilton Allergy
🇨🇦Hamilton, Ontario, Canada
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
FACET Dermatology
🇨🇦Toronto, Ontario, Canada
Alpha Recherche Clinique
🇨🇦Quebec, Canada
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
🇨🇳Zhenjiang, Jiangsu, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, Shanghai, China
Zhejiang Provincial People's Hospital
🇨🇳Hangzhou, Zhejiang, China
Renmin Hospital of Wuhan University
🇨🇳Wuhan, China
Allergo-Derm Bakos Kft
🇭🇺Szolnok, Jász-Nagykun-Szolnok, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
🇭🇺Kaposvár, Somogy, Hungary
Markusovszky Egyetemi Oktatokorhaz
🇭🇺Szombathely, Vas, Hungary
Medmare Bt
🇭🇺Veszprém, Veszprém City, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Yasumoto Dermatology Clinic
🇯🇵Chikushino-city, Fukuoka, Japan
Takagi Dermatological Clinic
🇯🇵Obihiro-shi, Hokkaido, Japan
Nomura Dermatology Clinic
🇯🇵Yokohama-city, Kanagawa, Japan
Dermatology and Ophthalmology Kume Clinic
🇯🇵Sakai City, Osaka, Japan
Nihonbashi Sakura Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Tachikawa Dermatology Clinic
🇯🇵Tachikawa, Tokyo, Japan
The Catholic University of Korea, Incheon St. Mary's Hospital
🇰🇷Bupyeong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan-si, Kyǒnggi-do, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Pusan-Kwangyǒkshi, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Dongjak-gu, Seoul-teukbyeolsi [Seoul], Korea, Republic of
National Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Cryptex Investigación Clínica S.A. de C.V.
🇲🇽Cuauhtémoc, Ciudad De México, Distrito Federal, Mexico
RM Pharma Specialists
🇲🇽Mexico City, Distrito Federal, Mexico
Trials in Medicine
🇲🇽Mexico City, Distrito Federal, Mexico
Centro de Atención en Enfermedades Inflamatorias CATEI
🇲🇽Guadalajara, Jalisco, Mexico
Eukarya PharmaSite
🇲🇽Monterrey, Nuevo León, Mexico
Scientia Investigacion Clinica S.C.
🇲🇽Chihuahua, Mexico
Centro de Investigacion Clinica de Oaxaca
🇲🇽Oaxaca, Mexico
MICS Centrum Medyczne Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
Diamond Clinic
🇵🇱Krakow, Małopolskie, Poland
Specderm Poznanska
🇵🇱Bialystok, Podlaskie, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
🇵🇱Gdansk, Pomorskie, Poland
"DERMED" Centrum Medyczne Sp. z o.o.
🇵🇱Lodz, Łódzkie, Poland
Dermoklinika - Centrum Medyczne spółka cywilna M. Kierstan, J. Narbutt, A. Lesiak
🇵🇱Lodz, Łódzkie, Poland
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
New Taipei Municipal TuCheng Hospital
🇨🇳New Taipei City, New Taipei, Taiwan
Chung Shan Medical University Hospital
🇨🇳Taichung City, Taichung, Taiwan
Tri-Service General Hospital
🇨🇳Taipei City, Taipei, Taiwan
National Taiwan University Hospital - Hsinchu branch
🇨🇳Hsinchu, Taiwan
Taipei Medical University Shuang Ho Hospital
🇨🇳New Taipei, Taiwan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
🇨🇳Taoyuan, Taiwan